Medical instruments and techniques for treatment of gastro-esophageal reflux disease

ABSTRACT

Apparatus and methods for treating tissue at or near a sphincter provide for transluminal introduction of an energy delivery device. The device includes a tissue compression member to compress target tissue at or near the sphincter. A radiofrequency energy source is coupleable to the delivery device to deliver radiofrequency energy to the target tissue. Energy is delivered to heat the tissue to a desired temperature. The desired temperature is selected to induce an injury-healing response or to inducing shrinkage of collagen fibers in the target tissue to thereby reduce laxity in the target tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 11/656,062filed 22 Jan. 2007, which is a divisional of application Ser. No.10/375,505, filed Feb. 27, 2003 (now U.S. Pat. No. 7,167,758), which isa divisional of application Ser. No. 09/648,345, filed Aug. 25, 2000(now U.S. Pat. No. 6,535,768), which is a continuation of applicationSer. No. 09/258,006 filed Feb. 25, 1999 (now U.S. Pat. No. 6,197,022),which is a continuation of application Ser. No. 08/920,291, filed Aug.28, 1997 (now U.S. Pat. No. 5,957,920). This application relates to theinvention disclosed in Provisional application Ser. No. 60/024,974 filedAug. 30, 1996 and is also related to provisional Application Ser. No.60/022,790 filed Jul. 30, 1996, both of which by this reference areincorporated herein.

FIELD OF THE INVENTION

This invention relates to unique therapeutic instruments and techniquesfor delivering thermal energy to a target tissue volume or site in aninterior of a patient's body in a “non-invasive” manner for medicalpurposes, such as selective cell damage, cell necrosis, molecularcontraction or tissue stimulation. An exemplary embodiment of theinvention is a catheterlike device with a working portion that can beintroduced in a patient's urethra in a treatment for urinaryincontinence. A treatment for gastroesophageal reflux disease also maybe fashioned to increase the rigidity or the length of the loweresophageal sphincter (LES) by laying down a fiber matrix around the LES.The device delivers thermal energy to “subsurface” or extraluminaltissues at a precise pre-selected “target” site, at the same timeminimizing trauma to the wall around the lumen as well as tissuesoutward from the “target” site. The principal use of the exemplaryembodiment is to selectively damage cells around a patient's sphincterwhich thereafter causes population of the extracellular compartment ofthe injury site with a collage fiber matrix. The collagen matrix servesas a means of altering cellular architecture and thus the bio-mechanicalcharacteristics of the sphincter. The instrument of the invention alsomay be used to hydrothermally shrink such collagen fiber matrices in aperiodic treatment cycle to further “model” target tissue flexibility tofurther alter the bio-mechanics of the sphincter.

SUMMARY OF THE INVENTION

According to one aspect of the invention, an apparatus to treat a targettissue volume at or near a sphincter comprises a radiofrequency energydelivery device. The delivery device has a working end sized andconfigured for transluminal introduction into a patient and includes atissue compression member deployable to provide compression of targettissue at or near a sphincter. A radiofrequency energy source iscoupleable to the delivery device to deliver radiofrequency energy tothe target tissue to reduce laxity in the target tissue. In oneembodiment, the delivery device does not penetrate a wall of a bodylumen.

The tissue compression member may take various forms, such as alaterally extending extendable element or an inflatable structure.Compression of the target tissue modifies the extracellular fluidcontent of the target tissue to alter the tissue's resistance toelectrical energy. Compression of target tissue decreases the level ofextracellular fluid content of the tissue to increase the targettissue's resistance to radiofrequency energy while contemporaneouslyincreasing the extracellular fluid level in the surrounding tissuevolume.

Energy is delivered to heat the targeted tissue to a desiredtemperature. The desired temperature may be selected to stimulate aninjury-healing response that populates the targeted tissue with collagenfiber matrix in extracellular space.

Alternatively, the desired temperature may be selected to induceshrinkage of collagen fibers in the target tissue, e.g., in response todenaturing, cleaving or partially denaturing intermolecular cross-linkor hydrogen bonds.

Another aspect of the invention provides a method of treating tissue ator near a sphincter. A thermal energy delivery device having a tissuecompression member is introduced through a body lumen to a targetedtissue site at or near a sphincter. The tissue compression member isdeployed to provide compression of the target tissue at or near asphincter. Radiofrequency energy is delivered to the targeted tissue toinduce an injury-healing response. In one embodiment, energy is also bedelivered to induce shrinkage of collagen fibers in the targeted tissue.

Other subjects and objects of this disclosure relate to novel techniquesand instruments for the controlled modeling or remodeling of cellulararchitectures in the interior of a patient's body to alter thestructural support of tissue layers, the support within anatomicstructures such as organs or body conduits, or to alter thebiomechanical characteristics of tissue masses or volumes in theinterior of the body, including but not limited to soft tissues, organsand lumened structures (e.g., esophagus, urethra), such tissueshereafter referred to as a “target” tissue volume or mass.

In the prior art, site-specific thermal treatment of cellular tissues inthe interior of a patient's body generally require direct contact of thetargeted cellular tissues with a medical device such as an thermalelectrode, usually by a surgical procedure that exposes both thetargeted cellular tissue and intervening tissue to trauma. For example,various microwave, radiofrequency and light energy (laser) devices havebeen developed for intraluminal use to thermally treat intraluminaltissues as well as extraluminal tissue volumes to destroy malignant,benign and other types of cells and tissues in a wide variety ofanatomic sites. Tissues treated include isolated carcinoma masses, andmore specifically, organs such as the prostate. Such prior art devicestypically include a catheter or cannula which is used to carry aradiofrequency electrode or microwave antenna through an anatomic ductor conduit to the region of treatment to apply energy directly throughthe conduit wall into the surrounding tissue in all directions. Severetrauma often is sustained by the duct wall during the thermal energydelivery to extraluminal target tissues. Some prior art devices combinecooling systems to reduce trauma to the conduit wall. Such coolingmechanisms complicate the device and require that the device besufficiently large to accommodate this cooling system. Other prior artdevices use catheters with penetrating elements that are extendablethrough the duct wall to access the target tissue mass, such as a devicefor treating benign prostatic hyperplasia.

More in particular, the present invention discloses “non-invasive”techniques and instruments that utilize thermal energy to selectivelydamage or injure certain cells in a site-specific volume in the interiorof a body. By the term non-invasive, it is meant that the working end ofthe device does not penetrate the interior of the body through anyincision in tissue. The non-invasive working end of the device still maybe disposed in the interior of the body by passing through an orificeinto a lumen or duct in a body-however, the device will not penetrate awall of the orifice.

The non-invasive selective damage to cells in target tissues induces abiological response to the injury. Such a biological response includescell reproduction or repopulation along with the proliferation of afiber matrix of collagen in the extracellular space. Thus, thecontrolled modeling of the structural or mechanical characteristics oftargeted tissue volume is possible by creation of such a collagen fibermatrix therein. Such selective injury to particular cell volume isaccomplished by modifying the extracellular fluid content (ECF) so as toincrease its resistance (R) to RF energy when compared to thesurrounding tissue volume, thus causing site-specific thermal energydelivery to selectively injure a certain cell population.

Various terms may be suitable for describing either elements of theprocess of thermal modeling of tissue by altering the bio-mechanicalcharacteristics of the targeted tissue volume with the creation of acollagen matrix in the extracellular space. Terms such as inducingconnective tissue formation, aggregating fibrous tissue, inducing theformation of scar tissue, tissue massing or tissue bulking, fibrosis,fibrogenesis, fibrillogenesis, etc. have been used.

Various other terms have been used to describe the thermal effects oncollagen molecules or fibers in the interior of the body and deal withdimensional chances—such as tissue shrinkage, molecular (both intra- andintermolecular) shrinkage, cellular (both intra- and extracellular)shrinkage or contraction, contracture, etc. For clarity of presentation,this disclosure will use the terms “modeling” to describe an object of atreatment. Other various terms relating to the formation of aextracellular “collage matrix” or “matrices” having “fiber”characteristics will be used for the purpose of describing more specificobjects of the invention. When referring to reducing dimensional changesin a tissue volume, whether at the cellular or intracellular level, theterms “shrinkage” or “contraction” will be used. These terms are thusinclusive of the aforementioned words, and all, other phrases andsimilar terms that relate to biophysical phenomena of collagen matrixformation and tissue modeling described in more detail below. The abovedescribed objects or the invention are accomplished by controlledmanipulation of bio-physical actions or phenomena relating to (i)induction of the injury healing response within a tissue volume in theinterior of a body to populate the volume with a collagen fiber matrixof in the extracellular space. The objects of the invention furtherinclude (ii) the selective hydrothermal shrinkage of collagen fibers inthe target tissue volume of surrounding tissue volumes subsequent to, orduring, the injury healing response.

As background, the injury healing response in a human body is complexand first involves an inflammatory response. A very mild injury willproduce only the inflammatory reaction. More extensive tissue trauma—nomatter whether mechanical, chemical or thermal—will induce the injuryhealing response and cause the release of intracellular compounds intothe extracellular compartment at the injury site. This disclosurerelates principally to induction of the injury healing process bythermal energy delivery; the temperature required to induce the processranging from about 45 to 65° C. depending on the target tissue and theduration of exposure. Such a temperature herein is referred to as T_(cd)(temperature level that causes “cell damage” to induce the injuryhealing response). It is important to note that the temperaturenecessary to cause cell damage may be substantially lower than thetemperature (T_(sc)) necessary to shrink collagen fibers describedbelow.

In order to selectively damage cells to induce the population of theextracellular compartment with a collagen fiber matrix, “control” of theinjury to a particular tissue volume mass is essential. In thisdisclosure, a thermal energy source is provided to selectively inducethe injury healing response, and more particularly an RF source. (Itshould be appreciated that other thermal energy devices are possible,for example a laser with or without a diffuser mechanism, or shortwave,microwave or ultrasound). In an RF energy delivery mechanism, a highfrequency alternating current (e.g., from 100,000 Hz to 500,000 Hz) isadapted to flow from a series of parallel electrodes into tissue. Thealternating current causes ionic agitation and friction in the targettissue mass as the ions follow the changes in direction of thealternating current. Such ionic agitation or frictional heating thusdoes not result from direct tissue contact with an electrode. In thedelivery of energy to a soft tissue mass, I=E/R where I is the intensityof the current in amperes, E is the energy potential measured in voltsand R is the tissue resistance measured in ohms. In such a soft tissuemass, “current density” or level of current intensity is an importantgauge of energy delivery which relates to the impedance of the tissuemass (I_(tc) is impedance of target cells). The level of heat generatedwithin the target tissue mass thus is influenced by several factors,such as (I) RF current intensity, (ii) RF current frequency, (iii)cellular impedance (I_(tc)) levels within the target cells, (v) heatdissipation from the target tissue mass; duration of RF delivery, and(vi) distance of the tissue mass from the electrodes. Thus, an object ofthe present invention is the delivery of “controlled” thermal energy toa target tissue volume by utilizing a computer-controlled system to varythe duration of current intensity and frequency based on sensor feedbackmechanisms.

The novel techniques disclosed herein also delivery thermal energy in(i) a site-specific manner to a target tissue volume, and (ii) in amanner that does not injure surface tissue while at the same timedelivering sufficient energy to damage subsurface cells. The noveltechniques are adapted to manipulate (compress or decompress) the targettissue volume to alter regional cell or tissue impedance (I_(tc)). Moreparticularly, in soft tissues which are the subject of this disclosure,there is a varying amount of extracellular fluid (BCE) that has ameasurable ECF level. By altering the ECF level, and/or the ioniccharacter of the fluid, the thermal energy that is delivered to a targetsite will generate differing levels of extracellular temperatureresulting in altered levels of cell damage (from different currentdensity). For example, mechanical compression of a target tissue volumewill lower the volume's ECF level in a subsurface site-specific region,the tissue volume thus increasing in impedance (I_(tc)) and becomingmore of a resistor. At the same time, the surface tissues are lesssusceptible to ECF alteration by such mechanical compression whichallows the temperature in the subsurface target volume to reach theT_(cd) (cell damage temperature) without ablation of the surface layer.

In the initial cellular phase of injury healing, granulocytes andmacrophages appear and remove dead cells and debris. In the subsequentearly stages of inflammation, the inflammatory exudate containsfibrinogen which together with enzymes released from blood and tissuecells, cause fibrin to be formed and laid down in the area of theinjury. The fibrin servos as a hemostatic barrier and acts as a scaffoldfor repair of the injury site. Thereafter, fibroblasts migrate andeither utilize the fibrin as scaffolding or for contact guidance thusfurther developing a fiber-like scaffold in the injury area. Thefibroblasts not only migrate to the injury site but also proliferate.During this fibroplastic phase of cellular level repair, anextracellular repair matrix is laid down that is largely comprised ofcollagen. Depending on the extent of the injury to tissue, it is thefibroblasts that synthesize collagen within the extracellularcompartment as a connective tissue matrix including collage (hereafternascent collagen), typically commencing about 36 to 72 hours after theinjury.

Thus, in the healing response in a human body, tissue repair occursprincipally by fibrous tissue proliferation rather organ regeneration.Most compound tissues or organs (e.g., epithelium which is a tissue) arerepaired by such fibrous connective tissue formation. Such connectivetissue matrices are the single most prevalent tissue in the body andgive structural rigidity or support to tissue masses or layers. Theprincipal components of such connective tissues are three fiber-likeproteins-principally collagen, along with reticulin, elastin and aground substrate. The bio-mechanical properties of fibrous connectivetissue and the repair matrix are related primarily to the fibrousproteins of collagen and elastin. As much as 25% of total body proteinis native collagen. In repair matrix tissue, it is believed that nascentcollagen is well in excess of 50%.

A brief description of the unique properties of collagen is required.Collagen (native) is an extracellular protein found in connectivetissues throughout the body and thus contributes to the strength of themusculo-skeletal system as well as the structural support of organs.Five types of collagen have been identified that seem to be specific tocertain tissues, each differing in the sequencing of amino acids in thecollagen molecule. Type I collagen is most commonly found in skin,tendons, bones and other connective tissues of the integument. Type IIIcollagen is most common in muscles and other more elastic tissues.

It has been previously recognized that collagen (or collagen fibers aslater defined herein) will shrink or contract when elevated intemperature to the range about 22 to 30 degrees above normal bodytemperature, herein referred to as T_(sc) (temperature to shrinkcollagen) (about 60° to 70° C.).

Extracellular collagen consists of a continuous helical molecule made upof three polypeptide coil chains. Each of the three chains isapproximate equal length with the molecule being about 1.4 nanometers indiameter and 300 nm, in length along its longitudinal axis in itshelical domain (medial portion of the molecule). The spatial arrangementof the three peptide chains is unique to collagen with each chainexisting as a right-handed helical coil. The superstructure of themolecule is represented by the three chains being twisted into aleft-handed superhelix. The helical structure of each collagen moleculeis bonded together by heat labile intermolecular cross-links (orhydrogen cross-links) between the three peptide chains providing themolecule with unique physical properties, including high tensilestrength along with moderate elasticity. Additionally, there exists atone heat stabile or covalent cross-link between the individual coils.The heat labile cross links may be broken by mild thermal effects thuscausing the helical structure of the molecule to be destroyed (ordenatured) with the peptide chains separating into individual randomlycoiled structures. Such thermal destruction of the cross-links resultsin the shrinkage of the collagen molecule along its longitudinal axis toapproximately one-third of its original dimension. The contraction ofcollagen fibers at from 60° C. to 70° C. is alternatively referred to asdenaturing, cleaving or partially denaturing the intermolecularcross-links or hydrogen bonds.

A plurality of col laden molecules (also called fibrils) aggregatenaturally to form collagen fibers that collectively make up the fibrousrepair matrix. The collagen fibrils polymerize into chains in ahead-to-tail arrangement generally with each adjacent chain overlappinganother by one forth the length of the helical domain in a quarterstagger fashion. The chains overlap in three dimensions and eachcollagen fiber reaches a natural maximum diameter, it is believedbecause the entire fiber is twisted resulting in an increased surfacearea such that succeeding layers of collagen molecules cannot bond withcontact points on underlying layers in the quarter-stagger arrangement.

It is believed that there exist pre-denaturational changes in collagenfibrils and fibers due to elevation of heat which include (i) initialdestabilization of the intramolecular cross-links, (ii) destabilizationof the intermolecular cross-links, (ii) partial helix-to-coiltransformations associated with denaturation of some or bothintramolecular and intermolecular cross-links, and (iii) completedenaturation of some, but not all, molecules making up a collagenfibrils. Such pre-denaturational changes all result in partialcontraction or shrinkage of collagen fibers in a collagen-containingtissue volume. By the term “partial denaturation” or “at least partialdenaturation” as used herein which are associated with a method of theinvention, it is meant that at least some (but probably not all) of theheat labile crosslinks of the collagen molecules making up a collagenfiber are destabilized or denatured thus causing substantial contractionof collagen fibers in a tissue mass. It is believed that such at leastpartial denaturation of the collagen fibers will result in shrinkage ofthe collagen and “tightening” of a collagen-containing tissue volume upto about 50 to 60 percent of its original dimensions (or volume).

Thus, the present invention is directed to non-invasive techniques andinstruments for controlled thermal energy delivery to a selected tissuevolume in the interior of a body to: (i) selectively injure certaincells in the target tissue volume to induce the biological injuryhealing response to populate the extracellular compartment with a fibermatrix thereby altering the structural support or flexibilitycharacteristics of the target tissue volume; and optionally (ii) tocause the shrinkage of either “native” collagen or “nascent” collagen inthe tissue volume to further alter bio-mechanical characteristics of thetissue volume.

More in particular, the thermal energy delivery (TED) device of thepresent invention has a catheter-like form with a proximal control endand a distal working portion dimensioned for transluminal introduction.The working portion has radiused laterally-extending elements that aredeployable to engage target issues on either side of the patient'ssphincter. RF electrodes are carried on the working faces of theopposing laterally-extending elements for delivering thermal energy tothe target tissues. Thus, the working portion of device is capable ofsite specific compression of the target tissue to decrease the level ofextracellular fluid (ECF) of the tissue to increase its resistance to RFenergy. What is important is that the resistance is increased onlylocally within the target tissue volume by lowering of the ECF levelwhile contemporaneously increasing the ECF level in the surroundingtissue volume. Thus, the interior of the target tissue may be thermallyelevated to a T_(cd) (temperature for cell damage) while at the sametime the wall surface around the urethra should not be ablated due bythe thermal energy delivery.

The therapeutic phase commences and is accomplished under variousmonitoring mechanisms, including but not limited to (i) directvisualization, (ii) measurement of tissue impedance of the target tissuevolume, and (iii) utilization of ultrasound imaging before and duringtreatment. The physician actuates the pre-programmed therapeutic cyclefor a period of time necessary to elevate the target tissue volume to(temperature of cellular damage) which is from 45′ to 65′ depending onduration.

During the therapeutic cycle, the delivery of thermal energy isconducted under full-process feedback control. The delivery of thermalenergy induces the injury healing response which populates the volumewith an extracellular collagen matrix which after a period of from 3days to two weeks increases pressure on the sphincter. The physician maythereafter repeat the treatment to further model, the cellulararchitecture around the sphincter.

In subsequent therapeutic treatment cycles, the delivery of thermalenergy may be elevated to at least partially denature collagen fibers inthe extracellular matrix without damage or substantial modification ofsurrounding tissue masses at a range between 60° to 80° C. The effect ofcollagen shrinkage will further stiffen the treated tissue volume tofurther increase extraluminal pressures on the sphincter.

In general, the present invention advantageously provides technique anddevices for creating preferential injury to a cellular volume in asubsurface target tissue.

The present invention provides techniques and instruments for alteringthe flexibility or bio-mechanical characteristics of subsurface targettissues.

The present invention provides a novel non-invasive devices andtechniques for thermally inducing the injury healing process in theinterior of the body without penetration of a tissue wall with aninstrument.

The present invention provides an instrument and technique for modifyingextracellular fluid content (ECF) of a target tissue volume to alter thetissue's resistance to electrical energy.

The present invention advantageously provides an electrode array forelevating current density from an electromagnetic (thermal) energysource in “surface” tissues to a lesser level while simultaneouslyelevating current density in “subsurface” tissues to a higher level.

The present invention advantageously provides a thermal energy deliverydevice which gives the operator information about the temperature andother conditions created in both the tissue targeted for treatment andthe surrounding tissue.

The present invention provides a device that is both inexpensive anddisposable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of a the present invention with theworking portion in an insertion configuration.

FIG. 2 is an elevational view of device of FIG. I with the workingportion in a deployed configuration.

FIG. 3 is an enlarged perspective view of components of the workingportion of the device of FIG. 1 de-mated from one another.

FIGS. 4A-4C are enlarged elevational views of the components of theworking portion of FIG. 1 in various positions.

FIG. 5 is a transverse sectional view of the device of FIG. 1 takenalong line 5-5 of FIG. 4A.

FIG. 6 is a block diagram of a control portion of the invention thatincludes a computer controller and energy source.

FIGS. 7A-7D are a sequence of sectional views of a patient's bladder andurethra showing the manner in which the instrument of FIG. 1 isillustratively utilized to perform a method of the invention inthermally treating tissue around the patient's sphincter; FIG. 7A beinga sectional views of the initial to of introducing the device into theurethra; FIG. 7B being a view of actuating certain laterally-extendingelements of the working portion in the patient's bladder; FIG. 7C beinga view of actuating certain laterally-extending elements of the workingportion in the patient's urethra; FIG. 7D being a view of approximatingthe laterally-extending elements to compress tissue therebetween toalter extracellular fluid content therein to facilitate anelectrosurgical treatment.

FIG. 8 is an enlarged sectional view of the compression of target tissueand the delivery thermal energy taken along line 8-8 of FIG. 7D.

FIG. 9 is another enlarged sectional view of the compression of targettissues similar to FIGS. 7D and 9 showing optional current vectors.

FIGS. 10A-10C are plan views of a working portion of a Type “B”embodiment of thermal energy delivery device.

FIGS. 11A-11B are plan views of an alternative embodiment of the workingportion of the Type “B” embodiment of FIG. 10A.

FIGS. 12A-12B are perspective and sectional views of a working portionof a Type “C” embodiment of thermal energy delivery device.

DETAILED DESCRIPTION OF THE INVENTION I. Type “A” Embodiment of ThermalEnergy Delivery (TED) Device

Referring to FIG. 1, a Type “A” embodiment of the present invention isshown that is adapted for transluminal introduction to treat specifictarget tissue regions around a patient's sphincter. As shown in FIG. 1,thermal energy delivery (TED) system 5 comprises elongate flexible outercatheter sleeve 10 dimensioned for transluminal passage with proximalend 11 and distal and 12 and extending along axis 15. First distalhandle portion 16 is coupled to proximal end 11 of the outer sleeve.Catheter 10 has axial lumen 18 extending therethrough for accommodatingthe reciprocation of co-axial inner sleeve 20 with working portion 25coupled to both inner and outer sleeves as described below. Secondproximal handle portion 26 is coupled to proximal end 21 of the innersleeve 20. Inner sleeve 20 with proximal end 21 and distal end 22 has(optional) lumen 28 therein dimensioned to slidably receive a fiberscopeor so that system 5 may be introduced over a guide catheter or scope(not shown).

Referring to FIGS. 3 and 4A, working portion 25 of system 5 comprisestwo cooperating tissue-engaging or tissue-compression members 30 and 32of any suitable material and is described in this embodiment as made ofa flexible plastic material. FIG. 3 shows tissue-compression members 30and 32 de-mated from one another and de-mated from outer and innercatheter sleeves, 10 and 20. Proximal member 30 is coupled to distal end12 of outer sleeve 10. Distal tissue-compression member 32 is coupled todistal end 22 of inner sleeve 10. Tissue-compression member 30 hasproximal end 40 a and distal end 40 b and tissue-compression member 32has proximal end 42 a and distal end 42 b. FIG. 3 also shows a pluralityof cooperating longitudinal keys 43 a (collectively) in members 30 and32 maintain angular registration between the tissue compression membersand allows for their axial reciprocation relative to one another asdescribed below.

Referring now to FIGS. 4A-4C, it can be seen that working portion 25 ismovable between a (first) insertion configuration (FIG. 4A) and a(second) deployed configuration (FIG. 4B). In the insertionconfiguration of FIG. 4A, each tissue-compression member 30 and 32 haslaterally-extending elements in a (first) repose position. In thedeployed configuration of FIG. 4B, the tissue-compression members 30 and32 have laterally-extending elements in a (second) articulated position.For example, member 30 has three laterally-extending elements or armportions 45 a-45 c that flex outwardly away from axis 15 of workingportion 25. Each arm is shown with living-type hinges wherein the entiremember 30 is of a resilient plastic. In general, proximal slidingmovement of inner sleeve 20 within bore 18 of outer sleeve 10 by meansof moving handle portion 26 in the proximal direction relative to handle16 (FIGS. 1-2) causes proximal end 40 a and distal end 40 b of member 30to be compressed axially toward one another resulting in arms 45 a-45 cflexing at living hinge points 46, 47 and 48 (collectively).Tissue-compression member 32 has three cooperating arm portions 47 a-47c that flex outwardly (similar to counterpart member 30) at equivalenthinge points (not numbered). It should be appreciated that the number ofarms 45 a-45 c and 47 a-47 c may be from one to four or more and forconvenience are shown as numbering three. FIGS. 3 and 4B show thatdistal end 22 of inner sleeve 20 is coupled to shaft portion 50 andshaft 50 is fixed to distal end 42 b of member 32 thus allowing proximalend 42 a (and bore portion 52 therein) of member 32 to slide over shaft50.

FIG. 4B, shows that each laterally-extending elements or arms 45 a-45 cof member 30 have radiused working faces 55 (collectively) that aresomewhat rounded for engaging tissue such that the tissue will not bepenetrated. Similarly, arms 47 a-47 c of member 32 have radiused workingfaces 56 (collectively).

Means are thus provided for altering the extracellular fluid (ECF)content of tissue engaged by the laterally-extending elements of workingend 25 by tissue compression. As can be seen in FIGS. 4A-4B, arms 45a-45 c and 47 a-47 c define gap 58 therebetween for engaging targettissue and thereafter compressing the targeted tissue sites. Additionalaxial reciprocating means are provided for reducing the axial dimensionof gap 58 after the arms are deployed as shown in FIG. 4B. By comparingFIGS. 48 and 4C, it can be seen that gap 58 is capable of moving frominitial dimension A to reduced dimension A′ when inner sleeve 20 ismoved axially relative to outer sleeve 10 and overcomes the springconstant of helically wound extension spring 59 that is disposed betweenopposing annular faces (60 a and 60 b) of members 30 and 32,respectively (see FIG. 3). The spring constant of spring 59 is strongerthan the collective spring constants of the living hinges (e.g., 47-49)of the arm elements described above. Thus, initial proximal axialmovement of inner sleeve 20 relative to outer sleeve 10 causes arms 45a-45 c and 47 a-47 to deploy (FIG. 4B). Additional proximal axialmovement of inner sleeve 20 relative to outer sleeve 10 causes workingraces 55 and 56 of the arms to move closer axially (FIG. 4C).

It should be appreciated that a variety of spring loading mechanisms maybe used to actuate the arm elements in a particular sequence.Preferably, the first proximal axial movement of inner sleeve 20relative to outer sleeve 10 will causes arms 47 a-47 c of member 32 todeploy. The second or next proximal axial movement of inner sleeve 20relative to outer sleeve 10 will cause arms 45 a-45 c of member 30 todeploy. In other words, two steps may be required to move working end 25to the configuration of FIG. 4B from the configuration of FIG. 4A.Finally, the next or third proximal axial movement of inner sleeve 20relative to outer sleeve 10 will cause gap 58 to be reduced from A to A′(see FIG. 4C). The control end (handles 16 and 26) of the devicepreferably may be locked (not shown) by any suitable means to maintainmembers 30 and 32 in the articulated position. Further, the control endmay comprise any suitable mechanism for actuating the working end, e.g.,a lever arm, trigger, etc., and is shown as cooperating slidable handles16 and 26 for convenience only.

Thermal energy delivery means are provided for thermally treating targettissue engaged or compressed between working faces 55 and 56. Conductiveelectrodes or electrode arrays 70 and 72 (collectively) for deliveringRF energy are shown carried in respective working faces 55 and 56. Eachelectrode preferably is individually controlled as described furtherbelow. FIG. 5 shows that the walls of outer sleeve 10 and inner sleeve20 have embedded therein individual current-carrying wires 75 a and 75 bthat supply RF energy to each conductive electrode. Both groups of theelectrodes 70 and 72 are shown in FIGS. 4A-4C as being bipolar but theelectrodes may be operated in a mono-polar fashion with a groundplate(not shown). Electrode material may include gold, nickel titanium,platinum, stainless steel, aluminum and copper. Referring to FIGS. 1-2,electrical cables 77 (collectively) are connected to an RF energy sourcethrough a controller described below which is adapted to deliver energyto electrodes 70 and 72.

Referring back to FIGS. 3 and 4A-4C, it can be seen that a sensor arrayof individual sensors 80 (collectively) is provided in a spacedrelationship around working end 25 and arms 45 a-45 c and 47 a-47 c. Thesensor array typically will include temperature sensors, thermistors(temperature sensors that have resistances that vary with thetemperature level) and/or impedance sensing elements that measure tissueimpedance in various conventional manners, although impedancemeasurement may obtained through electrodes 70 and 72 without resort todedicated electrodes and circuits for impedance measuring purposes.

The electromagnetic energy delivery source 88, for example, may beassumed to be an RF generator delivering energy to electrode 70 and 72.A multiplexer 90 is depleted in FIG. 6 which is operatively connected toeach electrode for measuring current, voltage and temperature at thermalsensors 80 (collectively) spaced around working end 25 or individuallyassociated with each electrode.

Multiplexer 90 is driven by a controller 100 which typically is adigital computer with appropriate software. The controller typicallywould include a CPU coupled to the multiplexer through a bus. On thecontroller system, there may be a keyboard, disk drive or othernon-volatile memory system, displays as are well known in the art foroperating the system. Such an operator interface may include varioustypes of imaging systems for observing the treatment such as thermal orinfrared sensed displays, ultrasonic imaging displays or impedancemonitoring displays.

For such an operator interface, current supplied to individualelectrodes along with voltage may be used to calculate impedance.Thermal sensors 80 carried in a position proximate to electrodes 70 and72 together with thermal sensors 102 positioned within RF generator areadapted to measure energy delivery (current and voltage) to eachelectrode at a treatment site during a treatment cycle. The outputmeasured by thermal sensors 80 and 102 are fed to controller 100 tocontrol the delivery of power to each electrode site. The controller 100thus can be programmed to control temperature and power such that acertain particular temperature is never exceeded at the treatment site.The operator further can set the desired temperature which can bemaintained. The controller has a timing feature further providing theoperator with the capability of maintaining a particular temperature atan electrode site for a particular length of time. A power deliveryprofile may be incorporated into controller 100 as well as a pre-set fordelivering a particular amount of energy. A feedback system or feedbackcircuitry can be operatively connected to impedance measuring system,the temperature sensors and other indicators at the controller 100 orwithin the power source 88.

The controller software and circuitry, together with the feedbackcircuitry, thus is capable of full process monitoring and control offollowing process variables: (i) power delivery; (ii) parameters ofselected particular treatment cycle, (iii) mono-polar or bi-polar energydelivery; and (iv) flow rate of coolant to insulator wall portion of theintroducer sheath if cooling is provided. Further, the controller candetermine when the treatment is completed based on time, temperature orimpedance or any combination thereof. The above-listed process variablescan be controlled and varied in response to tissue temperatures measuredat multiple sites on tissue surfaces in contact with the device as wellas by impedance to current flow at measured at each electrode whichindicates the current carrying capability of the tissue during thetreatment process. Additionally, controller 100 can providemultiplexing, can monitor circuit continuity for each electrode anddetermine which electrode is delivering energy.

FIG. 6 shows a block diagram of a particular embodiment of controlcircuitry. Note that thermal sensors can be thermistors which providediffering resistance levels depending on temperature. Amplifier 105 canbe a conventional analog differential amplifier for use with thermistorsand transducers. The output of amplifier 105 is sequentially connectedby analog multiplexer 90 to the input of analog digital converter 110.The output of amplifier 105 is a particular voltage that represents therespective sensed temperatures. The digitized amplifier output voltagesare supplied to microprocessor 115. Microprocessor 115 thereaftercalculates the temperature and/or impedance of the tissue site inquestion. Microprocessor 115 sequentially receives and stores digitaldata representing impedance and temperature values. Each digital valuereceived by microprocessor corresponds to a different temperature orimpedance at a particular site.

The temperature and impedance values may be displayed on operatorinterface as numerical values. The temperature and impedance values alsoare compared by microprocessor 115 with pre-programmed temperature, andimpedance limits. When the measured temperature value or impedance valueat a particular site exceeds a pre-determined limit, a warning or otherindication is given on operator interface and delivery ofelectromagnetic to a particular electrode site or area can be decreasedor multiplexed to another electrode. A control signal from themicroprocessor may reduce the power level at the generator or powersource, or de-energize the power delivery to any particular electrodesite. Controller receives and stores digital values which representtemperatures and impedance sent from the electrode and sensor sites.Calculated wall surface temperatures within the urethra and the bladdermay be forwarded by controller 100 to the display and compared to apredetermined limit to activate a warning indicator on the display.

II. Method of Use of Type “A” Embodiment

Operation and use of the catheter shown in FIG. 1 in performing a methodof the present invention can be described briefly as follows. Assumethat the physician wishes to (i) initially thermally treat targettissues around the patient's bladder sphincter to alter the cellulararchitecture therein; and optionally (ii) to subsequently thermallytreat the target tissues to contract the extracellular collagen matrixinduced therein by the initial thermal treatment.

FIG. 7A is a schematic cross-sectional drawing of the lower femaleanatomy during use of the instrument and method of the invention. Theurethra 102 extends from the bladder 104 within fat pad 106. Urinaryincontinence is a condition characterized by a malfunctioning sphincter108 often caused by movement or slippage of the bladder relative topubic bone 110 within pad 106 and other regional anatomic structures. Asshown in FIG. 7A, in the method of this invention, the catheter system 5is passed upwardly through the urethra 102 into the bladder 104 in theinsertion configuration (see FIG. 1). The position of working portion 25is precisely controlled using an ultrasound image, for example, obtainedfrom signals received from the conventional ultrasound transducer 125inserted into vagina 130 adjacent to the bladder or with an ultrasoundtransducer positioned outside the body (not shown). The catheter systemalternatively may be introduced over a fiberscope previously insertedinto the patient's urethra (not shown).

With the distal or terminal portion of working end 25 in the bladder,the surgeon then moves handle portion 26 (FIG. 1) and inner sleeve 20proximally a first distance relative to outer sleeve 10 and handle 16.As can be seen in FIG. 7B, such actuation moves arm elements 47 a-47 claterally away from or outward relative to axis 15 to a first deployedposition of working portion 25 thus pressing working faces 56 (andelectrodes 72) of the arms against walls 132 of bladder 104.

Thereafter, the physician may angularly rotate the entire catheter aboutits axis td orient one or more of the arm elements toward tissues to betreated. The physician then moves handle portion 26 (FIG. 1) and innersleeve 20 proximally a second distance relative to outer sleeve 10. Ascan be seen in FIG. 7C, such further actuation moves arm elements 45a-45 c to a second deployed position being within the urethra 102 suchthat working faces 55 of the these arms along with electrodes 70 arelaterally extended somewhat deep into the target tissues indicated at S.The curvature and radiusing of working faces 50 insure that the arms donot penetrate the walls 135 of the urethra. Finally, as shown in FIG.7G, the physician moves handle portion 26 and inner sleeve 20 proximallya third distance relative to outer sleeve 10 thereby moving arm elements45 a-45 c and 47 a-47 c (a third deployed position) closer together tocompress target tissue S therebetween (see FIG. 4C).

Referring to FIG. 8, the compression of target tissue S between workingfaces 55 and 56 reduces the extracellular fluid (ECF) content in tissueS thus increasing tissue S's resistance to RF current. Thus, delivery ofRF current through either electrodes 70 or 72 will, allow tissue S to beelevated to T_(cd) (temperature or cell damage) to induce the injuryhealing response while surface layer L remains at a lower temperaturesuch that the surface layers will not be ablated, principally due to thefact that surface layer L has a lower resistance (R) due to its higherECF level as well, as the fact that evaporative and convective forcesfurther reduce the temperature of surface layer L indicated by arrows138.

Still referring to FIG. 8, it further should be appreciated thatreduction of ECF level in target tissue S tends to increase the ECFlevel in tissues W just outward or away from the most compressed targettissue S. The non-compressed tissue W thus will have a lesser resistanceto RF current (due to increased ECF content) and readily conducts the RFenergy to target tissue S. Thus, a temperature gradient will exist wherethe center of the region of target tissue S will be elevated to thehighest temperature (a higher current density) than region W. Surfacelayer L will have the lowest temperature due to increased ECF levels aswas tissue W as well as the evaporative/convective effects affectinglayer L mentioned above in other words, the compression of target tissuecaused it to act as a “fuse” or “fuse point” surrounded by moreconductive tissue volumes or layers. The center point 140 of targettissue S is thus a focus of the heating which is similar to a fuse.

Electrodes 70 and 72 on the arm elements are energized from RF energysource 88 by actuation of a switch in the control end (handle 16 or 26)of the catheter system 5 or from a foot pedal or other suitable means.Preferably, the time and/or power levels are preset by the controller100. The RF energy from energy source 88 is delivered to the targettissue S for a pre-selected time. Impedance also is monitored, and whenor if it exceeds a preset value, the energy source can be reduced orterminated automatically by controller 100. The temperature of surfacesof working portion 25 adjacent the urethral wall 135 and adjacent to thebladder wall 122 are also monitored using temperature sensors attachedto these components to precisely control the treatment parameters andprevent excessive heating of surface tissue layers L.

After target tissue S has sustained cell damage at the desired level,the physician may collapse the arms 45 a-45 c and 47 a-47 c back ontoworking portion and either rotate the catheter slightly and repeat thetreatment or remove the device from the patient's body.

It should be appreciated that arm elements, although shown as angularlysymmetric, may be asymmetric thus delivering energy to a target sites ina pre-determined asymmetric pattern.

One or more temperature sensors 80, which can be conventionalthermistors, thermocouples or even optical fibers communicating withexternal sensors, are positioned along the catheter or arm elements toprovide a temperature profile of the urethra adjacent to and preferablyon both sides the electrodes 70 and 72. This temperature profile can beused by the operator to prevent the temperature of the urethral wall orbladder wall from reaching level which would cause surface ablation. TheRF energy thus exposes the target tissue S to controlled heating toT_(cd) (temperature of cell damage) of approximately 45° C. to 65° C.Preferably, the temperature range is from 45° C. to 55° C. Still morepreferably, the temperature range is from 45° C. to 50° C.

The RF current typically is delivered between opposing electrodes 70 and72 in a bi-polar manner as shown by broken arrows in FIG. 8. In certainselected instances, more directed cell damage can be obtained byalternating the bi-polar flow of current in various vectors indicated bybroken arrows in FIG. 9. In other instances, one or more of theelectrodes may act as a mono-polar electrode and a delivery energy to agrounding plate (not shown). The RF treatment is continued until thecells in the target tissue S have been damaged as indicated by dottedlines in FIGS. 8 and 9. The cell damage induces the body's injuryhealing response which thereafter populates the extracellularcompartment with a collagen fiber matrix having the effect of bulkingtissue and reducing the flexibility of tissues as described above. Suchtissue bulking or tissue stiffening causes extraluminal pressures aroundthe sphincter and helps restore the sphincter's ability to pinch offurine flow. A similar procedure may be performed to enhance extraluminalpressures around the sphincter of the esophagus.

This procedure is unique in that it is the first transluminal procedurewhich selectively provides the ability to limit the treatment to theextraluminal target tissues and spares the normal tissue of the organwall from excessive temperatures. This procedure also minimizes thetrauma sustained by tissues surrounding urethra 102, especially whencompared to previously known procedures. The procedure may be carriedout under local anesthesia only, depending upon the rate of energydelivery and degree of pain sensation experienced by the patient. Whenlocal anesthetic is adequate, the procedure can be performed in thephysician's office. Such a procedure still could be provided on anoutpatient basis and would require a short term (1-3 hour) observation.If the procedure and patient require greater pain control, then spinalanesthesia or a general anesthesia may be used which would mandate theprocedure be carried out in the operating room.

Following a therapeutic cycle, the patient may return to normalactivities with careful monitoring of the sphincter function.Thereafter, perhaps on a bi-weekly or monthly basis, the identicaltreatment cycle may be repeated in a one or more subsequent cycles untilthe desired reduction in tissue flexibility and pressure on thesphincter is achieved. It is believed that such periodic treatments(e.g., from 1 to 3 treatments over a period of a few weeks) may be bestsuited to stiffen target tissue S and to correct sphincter function.

In the subsequent treatment cycles, the temperature profile may beprogrammed to attain the slightly higher level Tsc necessary to shrinkcollagen fibers in the extracellular collagen matrix induced by theoriginal treatment. The controller 100 and preprogrammed therapy cyclestill will allow the temperature of the organ wall to be low enough soas to prevent surface ablation by making the energy deliveryintermittent. The RF energy thus exposes the target tissue S tocontrolled heating to Tsc (temperature necessary to shrink collagen) ofapproximately 50° C. to 80° C. More preferably, the RF energy exposestissue S to controlled heating of approximately 60° C. to 70° C. Stillmore preferably, the RF enemy exposes tissue S to controlled heating ofapproximately 65° C. to 70° C.

III. Type “B” Embodiment of Thermal Energy Deliver, (TED) Device

Referring to FIGS. 10A-10C, a Type “B” embodiment of the presentinvention is shown that is adapted for transluminal introduction and issimilar in most respects to the first-described embodiment Likereference numerals refer to like components of the Type “A” and Type “B”devices.

The Type “B” device differs principally in that the distal tissuecompression member 32 that is coupled to the distal end 22 of innersleeve 20 carries an inflatable structure 150 rather than laterallyextendable elements. The inflatable structure 150 communicates with anyconventional pressure source (e.g., a syringe) through lumen 25 in thewall of inner sleeve 20 (FIG. 10). Preferably, inflatable structure 150is of a non-compliant material such as PET but also may be an elastomersuch as latex or silicone.

In use, the Type “B” embodiment is used in a fashion similar to thatdescribed above. First, the catheter is introduced into the organ andthen inflatable structure 150 is expanded. Thereafter, the proximal arms45 a-45 c are extended laterally to compress tissue between the arms 45a-45 c and inflatable structure 150. RF energy may be delivered is amonopolar fashion. Alternatively, the surface of the inflatablestructure 150 may have a plurality of opposing electrodes 152 and the RFenergy may be delivered in a bi-polar fashion as described previously.Another alternative embodiment of inflatable structure 150 could includea metallic mesh 155 as a return electrode covering a substantial portionof the surface of the inflatable structure facing electrodes 60 (seeFIGS. 11A-11B).

IV. Type “C” Embodiment of Thermal Energy Delivery (TED) Device

Referring to FIGS. 12A-12B, a Type “C” embodiment of the presentinvention is shown that is very similar to the first-described Type “A”embodiment. Like reference numerals refer to like at components of theType “A” device. This Type “C” working end 25 has the spring mechanismfor sequencing the articulation of laterally extending elements 45 a-45c and 47 a-47 c eliminated from the working end. The spring mechanismmay be moved to the handle end or control end of the instrument (notshown).

FIGS. 12A and 12B show more in particular how each laterally-extendingelement may be configured with four living hinges points 200 a, 200 b,200 c and 200 d to allow electrodes 70 to assume a face angle at about900 to axis 15. Each living hinge point comprises a reduced sectionaldimension of the resilient plastic of the member. Similarly, four livinghinges points 202 a, 202 b, 202 c, and 202 d allow electrodes 72 toassume a face angle at about 90° relative to axis 15. FIG. 12B showsthat by varying the lengths of the certain segments of the laterallyextending elements 45 a and 47 a, electrodes 70 and 72 may be alignedand opposed at a similar distance D from axis 15. In use, the Type “C”embodiment is used in a fashion similar as described above.

This disclosure is illustrative and not limiting. A though specificfeatures of the invention are shown in some drawings and not in others,this is for convenience only and any feature may be combined withanother in accordance, with the invention and are intended to failwithin the scope of the appended claims. Other aspects of the inventionare apparent from the drawings and accompanying descriptions of theinstrument and techniques of this invention which will be readilyapparent to a person skilled in the art that this procedure can be usedin many areas of the body in percutaneous approaches as well asapproaches through body orifices to thermally treat tissues around ananatomic duct.

1. An apparatus to treat a target tissue volume at or near a sphinctercomprising a radiofrequency energy delivery device having a working endsized and configured for transluminal introduction into a patient andincluding a tissue compression member deployable to provide compressionof target tissue at or near a sphincter, and a radiofrequency energysource coupleable to the delivery device to deliver radiofrequencyenergy to the target tissue to reduce laxity in the target tissue.